Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1129968
Name of medicinal product: MALARONE PAEDIATRIC
Active substances:
Estonian, English, Latin
ATC code: P01BB51
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 25mg+62,5mg
Amount in package: 12TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Prophylaxis of Plasmodium falciparum malaria in individuals weighing 11-40 kg. Note: For treatment of acute, uncomplicated Plasmodium falciparum malaria in individuals weighing 11-40 kg please refer to the Summary of Product Characteristics for MALARONE 250/100 mg tablets. MALARONE may be active against Plasmodium falciparum that are resistant to one or more other antimalarial agents. Therefore, MALARONE may be particularly suitable for prophylaxis against Plasmodium falciparum infections in areas where this species is known to be commonly resistant to one or more other antimalarial agents Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include WHO and public health authorities' guidelines.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated February 15, 2021)
Package information leaflet (PIL): EST  (last updated February 15, 2021)
Labelling:  (last updated December 21, 2018)
Last imported to Estonia: April 9, 2020
Marketing authorization holder: GlaxoSmithKline (Ireland) Limited 
Marketing authorization number: 425603 
Marketing authorization issued on: December 5, 2003 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: August 12, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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